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FDA 510(k) Application Details - K013396
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K013396
Device Name
Neurological Stereotaxic Instrument
Applicant
ALPHA OMEGA LTD.
HA'AVODA ST., P.O. BOX 810
NAZARETH ILLIT 17105 IL
Other 510(k) Applications for this Company
Contact
AJWAD AKASHI
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/15/2001
Decision Date
08/07/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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